Trial · NCT02285439
Study of MEK162 for Children With Low-Grade Gliomas
NCT02285439, Phase 1, Phase 2, Completed, Children's Hospital Los Angeles; results first posted 2025-10-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of MEK162 for Children With Low-Grade Gliomas. Trials, record NCT02285439. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02285439
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MEK162 for Children With Low-Grade Gliomas
- NCT number
- NCT02285439
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 105 participants, actual
- Lead sponsor
- Children's Hospital Los Angeles
- Conditions
- Low-Grade Gliomas, Malignant Neoplasms, Brain, Soft Tissue Neoplasms
- Interventions
- MEK162
- First posted
- 2014-11-07
- Last updated
- 2025-10-07
- Results first posted
- 2025-10-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate (Strata 1 and 2) | 48 weeks | For each stratum, the percentage of patients achieving at least a minor response (defined as greater than or equal to 25% decrease in maximal two dimensional measurements compared to baseline) during the first 12 cycles (nominally 48 weeks) of treatment will be reported. |
| Primary | 12 Cycle Progression-free and Overall Survival (Strata 1 and 2) | 48 weeks | Progression free and overall survival will be reported as Kaplan-Meier estimate who are alive without disease progression, alive with disease progression, deceased without disease progression, and deceased with disease progression 12 cycles (48 weeks) after treatment initiation. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate (Strata 1 and 2) | 48 weeks | Phase II Stratum 2 population n=22; Analysis population n=21. One patient enrolled to this stratum did not initiate treatment and was excluded from analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 12 Cycle Progression-free and Overall Survival (Strata 1 and 2) | 48 weeks | Phase II Stratum 2 population n=22; Analysis population n=21. One patient enrolled to this stratum did not initiate treatment and was excluded from analysis. | percentage of participants | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate (Strata 1 and 2) | Phase II Stratum 1 | 15 | Participants | ||
| Best Overall Response Rate (Strata 1 and 2) | Phase II Stratum 2 | 12 | Participants | ||
| 12 Cycle Progression-free and Overall Survival (Strata 1 and 2) | Phase II Stratum 1 | Progression Free Survival at 12 cycles | 59.1 | 95% Confidence Interval 37.1 to 75.7 | percentage of participants |
| 12 Cycle Progression-free and Overall Survival (Strata 1 and 2) | Phase II Stratum 2 | Progression Free Survival at 12 cycles | 90.0 | 95% Confidence Interval 65.6 to 97.4 | percentage of participants |
| 12 Cycle Progression-free and Overall Survival (Strata 1 and 2) | Phase II Stratum 1 | Overall Survival at 12 cycles | 95.8 | 95% Confidence Interval 73.9 to 99.4 | percentage of participants |
| 12 Cycle Progression-free and Overall Survival (Strata 1 and 2) | Phase II Stratum 2 | Overall Survival at 12 cycles | 100 | 95% Confidence Interval NA to NA | percentage of participants |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Dose Level 1 | 4 | |
| Overall Study | STARTED | Phase I Dose Level 2 | 3 | |
| Overall Study | STARTED | Phase I Dose Level 3 | 3 | |
| Overall Study | STARTED | Phase I Dose Level 4 | 3 | |
| Overall Study | STARTED | Phase I Dose Level 5 | 6 | |
| Overall Study | STARTED | Phase II Stratum 1 | 27 | |
| Overall Study | STARTED | Phase II Stratum 2 | 22 | |
| Overall Study | STARTED | Phase II Stratum 3 | 30 | |
| Overall Study | STARTED | Phase II Stratum 4 - Surgical Arm, Target Validation | 7 | |
| Overall Study | Dose Limiting Toxicity Evaluable | Phase I Dose Level 1 | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level 1 | 0 | 4 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level 2 | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level 3 | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level 4 | 0 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Phase I Dose Level 5 | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II Stratum 1 | 0 | 27 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II Stratum 2 | 2 | 21 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II Stratum 3 | 0 | 30 | |
| other | Anemia | Blood and lymphatic system disorders | Phase II Stratum 4 (Surgical Arm, Target Validation) | 0 | 7 | |
| other | Left ventricular systolic dysfunction | Cardiac disorders | Phase I Dose Level 1 | 0 | 4 |
1 to 10 of 1,116Source ClinicalTrials.gov
See all 1,116 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I Dose Level 1 | 0 | 4 |
| Total, all-cause mortality | Phase I Dose Level 2 | 0 | 3 |
| Total, all-cause mortality | Phase I Dose Level 3 | 0 | 3 |
| Total, all-cause mortality | Phase I Dose Level 4 | 0 | 3 |
| Total, all-cause mortality | Phase I Dose Level 5 | 0 | 6 |
| Total, all-cause mortality | Phase II Stratum 1 | 0 | 27 |
| Total, all-cause mortality | Phase II Stratum 2 | 0 | 22 |
| Total, all-cause mortality | Phase II Stratum 3 | 0 | 30 |
| Total, all-cause mortality | Phase II Stratum 4 (Surgical Arm, Target Validation) | 0 | 7 |
| Total, other adverse events | Phase I Dose Level 1 | 1 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phase II Stratum 1 vs Phase II Stratum 2: Best Overall Response Rate (Strata 1 and 2) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02285439
GET https://conductscience.org/api/trials/v1/NCT02285439/flow?page=2